Pasithea Therapeutics, a biotechnology company focused on the discovery, research and development of treatments for central nervous system (CNS) disorders, has signed a contract with WuXi STA, a subsidiary of WuXi AppTec, to manufacture the active pharmaceutical ingredient (API) for its macrocyclic, next-generation MEK Inhibitor, PAS-004 (formerly CIP-137401).

After the completion of the pre-clinical testing and animal toxicology studies, GMP manufacturing is the final major requirement to support the company’s investigational new drug (IND) application with the U.S. FDA, which is expected in the second half of 2023.

WuXi STA is recognized as an industry leader in “end-to-end” chemistry, manufacturing, and controls (CMC) services, for both API and finished dosage forms, with extensive expertise and track record for meeting global quality standards.

“We are delighted to be working with WuXi STA, one of the largest and most well-respected contract, development, and manufacturing organizations (CDMOs) in the world,” said Tiago Reis Marques, CEO, Pasithea. “We remain on track with PAS-004 development and look forward to our IND submission followed by the initiation of our Phase 1 clinical trial.”

Graeme Currie, chief development officer of Pasithea, said, “WuXi STA has a proven track record of manufacturing success to FDA standards and we believe that their high-quality capabilities will support progression of our drug candidate into the clinic. PAS-004 has already received orphan drug designation from the FDA for neurofibromatosis 1, and we plan to start our phase 1 clinical trial in the second half of 2023.”